(M00021, V35)

The following is a list of the active Local Coverage Determinations (LCDs) that provide reasonable and necessary indications and limitations of Medicare coverage on policies supporting the MolDX program. 

For instructions on submitting reconsideration requests and other requests based on the Program Integrity Manual (PIM), use these links:

LCD Name
LCD Number
MolDX:  Circulating Tumor Cell Marker Assays
MolDX:  Genetic Testing for Lynch Syndrome
Controlled Substance Monitoring and Drugs of Abuse Testing
MolDX:  Biomarkers in Cardiovascular Risk Assessment
MolDX:  BRCA1 and BRCA2 Genetic Testing
MolDX:  CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing
MolDX:  HLA-B*15:02 Genetic Testing
MolDX:  HLA-DQB1*06:02 Testing for Narcolepsy
MolDX:  Molecular RBC Phenotyping
Bladder/Urothelial Tumor Markers
Coenzyme Q10 (CoQ10)
Flow Cytometry
MolDx:  4Kscore Assay
MolDX:  AlloSure® Donor-Derived Cell-Free DNA Test
MolDX:  APC and MUTYH Gene Testing
MolDX:  Breast Cancer Assay:  Prosigna
MolDX:  DecisionDx-UM (Uveal Melanoma)
MolDX:  EndoPredict Breast Cancer Gene Expression Test
MolDX:  Genetic Testing for BCR-ABL Negative Myeloproliferative Disease
MolDX:  Genetic Testing for Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR)
MolDX:  MGMT Promoter Methylation Analysis
MolDX:  Molecular Diagnostic Tests (MDT)
MolDX:  NRAS Genetic Testing
MolDX:  Oncotype DX® Breast Cancer for DCIS (Genomic HealthTM)
MolDX:  Oncotype DX® Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer
MolDX:  Percepta© Bronchial Genomic Classifier
MolDX:  ProlarisTM Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease
MolDX:  Prometheus IBD sgi Diagnostic Policy
MolDX:  Genomic HealthTM Oncotype DX® Prostate Cancer Assay
Special Histochemical Stains and Immunohistochemical Stains
GlycoMark Testing for Glycemic Control
In Vitro Chemosensitivity & Chemoresistance Assays
MolDX:  ProMark Risk Score
MolDX:  Genesight® Assay for Refractory Depression
MolDX:  ConfirmMDx Epigenetic Molecular Assay
MolDX:  Decipher® Prostate Cancer Classifier Assay
MolDX: ProlarisTM Prostate Cancer Genomic Assay
MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC) L37699
MolDX: Corus® CAD Assay L37612
MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels L37713
MolDX: Cystatin C Measurement L37581
MolDX: DecisionDX Melanoma L37725
MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) L37709
MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) L37701
MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test L37794
MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test L37857
MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease L37785
MolDX: MDS FISH L37602
MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer L37870
MolDX: myPath Melanoma Assay L37859

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